Method and system for improved measurement of localized oral inflammation using centroid sampling

ABSTRACT

For localizing gingival inflammation within a user&#39;s mouth the following steps are carried out using an oral care device ( 10 ): (i) sequentially emitting ( 520 ) light by a plurality of light sources ( 48 ) in a first sequential pattern, wherein at least some of the plurality of light sources are configured to emit light of different wavelengths; (ii) sequentially emitting ( 530 ) light in a second sequential pattern which is the reverse of the first sequential pattern; (iii) obtaining ( 540 ), by a light detector ( 40 ), reflectance measurements to generate first reflectance data from light emitted in the first sequential pattern, and to generate second reflectance data from light emitted in the second sequential pattern; (iv) averaging ( 550 ), by a controller ( 30 ), first reflectance data and second reflectance data for each wavelength to generate averaged reflectance data; and (v) determining ( 570 ), using the averaged reflectance data, whether gingiva at the location is inflamed.

FIELD OF THE INVENTION

The present disclosure is directed generally to methods and systems forimproved detection of localized gingival inflammation using an oral caredevice.

BACKGROUND

Proper tooth brushing, including length and coverage of brushing, helpspromote long-term dental health. Many dental problems are experienced byindividuals who either do not regularly brush their teeth or who do soinadequately, especially in a particular area or region of the oralcavity. Among individuals who do brush regularly, improper brushinghabits can result in poor coverage of brushing and thus surfaces thatare not adequately cleaned during a cleaning session, even when astandard brushing regimen, such as brushing for two minutes twice daily,is followed.

Indeed, it is estimated that 50% of the adult population in the UnitedStates is affected by periodontal disease, with severity of diseaseranging from gingivitis to periodontitis. However, consumers are oftennot able to detect early signs of periodontal disease. Accordingly, suchdiseases may only be detected during dental visits when the disease isalready advanced and significantly harder to treat.

Inflammation of tissues within the mouth is one of the key signs ofperiodontal disease. Detecting inflammation would signal the existenceof a disease state, and would alert the individual to the need fortreatment to address the issue. For example, inflammation of the gumscan be reversible with proper home care if it is detected, while boneloss from periodontitis will require professional treatment. However,existing methods and devices are unable to adequately identify orquantify inflammation of tissues, particularly localized inflammation.For example, handheld devices enable poor detection of gingivalinflammation, as these devices either analyze large areas of the mouthresulting in a large signal-to-noise ratio that interferes withdetection, or require so many measurements that they are not userfriendly. Additionally, the motion of a user's hand can result inartifacts and poor readings by a handheld device. As a result,periodontal disease is often not detected.

Accordingly, there is a continued need in the art for oral care methodsand devices that account for the motion of a user's hand during thedetection of localized gingival inflammation.

SUMMARY OF THE INVENTION

The present disclosure is directed to inventive methods and systems fordetecting tissue inflammation using an oral care device. Variousembodiments and implementations herein are directed to an oral caredevice configured to obtain measurements of gingival tissue to identifylocalized gingival inflammation. The oral care device comprises a sensorwith a configuration of one or more light emitters and one or morephotodetectors or imagers to obtain information about gingival tissue atone or more sampled locations. The one or more light emitters areconfigured to emit light such that a plurality of different wavelengthsare sequentially emitted in a first sequential pattern. The one or morelight emitters are further configured to subsequently emit light suchthat a plurality of different wavelengths are sequentially emitted in asecond sequential pattern, wherein the second sequential pattern is thereverse of the first sequential pattern. One or more light detectors areconfigured to obtain reflectance measurements from a location within theuser's mouth to generate first reflectance data for the location inresponse to light emitted in the first pattern, and to generate secondreflectance data for the location in response to light emitted in thesecond pattern. A controller of the device averages first reflectancedata and second reflectance data for each of the plurality of detectedlight wavelengths to generate averaged reflectance data for thelocation, which is then used to determine whether gingiva at thelocation is inflamed.

Generally in one aspect, a method for localizing gingival inflammationwithin a user's mouth using an oral care device is provided. The methodincludes: (i) sequentially emitting light by a plurality of lightsources of the oral care device in a first sequential pattern, whereinat least some of the plurality of light sources are configured to emitlight of different wavelengths to result in a plurality of emitted lightwavelengths; (ii) sequentially emitting light by the plurality of lightsources of the oral care device in a second sequential pattern, whereinthe second sequential pattern is the reverse of the first sequentialpattern; (iii) obtaining, by a light detector of the oral care device,reflectance measurements from a location within the user's mouth togenerate first reflectance data for the location in response to thelight emitted in the first sequential pattern, and to generate secondreflectance data for the location in response to the light emitted inthe second sequential pattern; (iv) averaging, by a controller of theoral care device, first reflectance data and second reflectance data foreach of the plurality of emitted light wavelengths to generate averagedreflectance data; and (v) determining, by the controller using theaveraged reflectance data, whether gingiva at the location is inflamed.

According to an embodiment, the method further includes the step ofdetermining, by the controller using averaged reflectance data, whetherthe location comprises gingiva.

According to an embodiment, the method further includes the step ofproviding information regarding whether gingiva at a location comprisesinflammation.

According to an embodiment, the oral care device comprises a pluralityof light detectors, each configured to obtain reflectance measurementsfrom a different location within the user's mouth to generatereflectance data for that respective location.

According to an embodiment, the step of determining whether gingiva at alocation is inflamed comprises determining an approximate tissueoxygenation level of the gingiva at each of the remaining plurality oflocations, wherein a low tissue oxygenation level indicates gingivainflammation.

According to an embodiment, the one or more light emitters and the oneor more light detectors are positioned such that a surface at thelocation is not directly illuminated by the plurality of light sources.

According to an embodiment, the first and/or second sequential patternfurther comprises a time point in which no light is emitted by theplurality of light sources.

According to an aspect is a method for localizing gingival inflammationusing an oral care device. The method comprises: (i) sequentiallydetecting, by one or more light detectors of the oral care device, lightemitted by one or more light sources of the oral care device, whereinthe one or more light detectors are configured to measure a plurality ofwavelengths in a first sequential pattern, and generating firstreflectance data from the detected light; (ii) sequentially detectinglight by the one or more light detectors of the oral care device in asecond sequential pattern, wherein the second sequential pattern is thereverse of the first sequential pattern, and generating secondreflectance data from the detected light; (iii) averaging, by acontroller of the oral care device, first reflectance data and secondreflectance data for each of the plurality of detected wavelengths togenerate averaged reflectance data; and (iv) determining, by thecontroller using the averaged reflectance data, whether gingiva at thelocation is inflamed.

According to an aspect is a device configured to localize gingivalinflammation within a user's mouth. The device includes: a plurality oflight sources configured to sequentially emit light in a firstsequential pattern and subsequently in a second sequential pattern,wherein the second sequential pattern is the reverse of the firstsequential pattern, and wherein at least some of the plurality of lightsources emit light of different wavelengths to result in a plurality ofemitted light wavelengths; a light detector configured to obtainreflectance measurements from a location within the user's mouth togenerate first reflectance data for the location in response to thelight emitted in the first sequential pattern, and to generate secondreflectance data for the location in response to the light emitted inthe second sequential pattern; and a controller configured to: (i)average first reflectance data and second reflectance data for each ofthe plurality of emitted light wavelengths to generate averagedreflectance data; and (ii) determine, using the averaged reflectancedata, whether gingiva at the location is inflamed.

According to an embodiment, the controller is further configured todetermine, from the averaged reflectance data, whether the locationcomprises gingiva.

According to an embodiment, the device further includes a user interfaceconfigured to provide information regarding whether gingiva at alocation comprises inflammation.

According to an aspect is a device configured to localize gingivalinflammation. The device includes: (i) one or more light detectorsconfigured to sequentially detect light emitted by one or more lightsources of the device, wherein the one or more light detectors areconfigured to measure a plurality of wavelengths in a first sequentialpattern to generate first reflectance data from the detected light, andfurther wherein the one or more light detectors are further configuredto sequentially detect light in a second sequential pattern to generatesecond reflectance data from the detected light, wherein the secondsequential pattern is the reverse of the first sequential pattern; and(ii) a controller configured to average first reflectance data andsecond reflectance data for each of the plurality of emitted lightwavelengths to generate averaged reflectance data, and furtherconfigured to determine, using the averaged reflectance data, whethergingiva at the location is inflamed.

As used herein for purposes of the present disclosure, the term“controller” is used generally to describe various apparatus relating tothe operation of an oral care apparatus, system, or method. A controllercan be implemented in numerous ways (e.g., such as with dedicatedhardware) to perform various functions discussed herein. A “processor”is one example of a controller which employs one or more microprocessorsthat may be programmed using software (e.g., microcode) to performvarious functions discussed herein. A controller may be implemented withor without employing a processor, and also may be implemented as acombination of dedicated hardware to perform some functions and aprocessor (e.g., one or more programmed microprocessors and associatedcircuitry) to perform other functions. Examples of controller componentsthat may be employed in various embodiments of the present disclosureinclude, but are not limited to, conventional microprocessors,application specific integrated circuits (ASICs), and field-programmablegate arrays (FPGAs).

The term “user interface” as used herein refers to an interface betweena human user or operator and one or more devices that enablescommunication between the user and the device(s). Examples of userinterfaces that may be employed in various implementations of thepresent disclosure include, but are not limited to, switches,potentiometers, buttons, dials, sliders, track balls, display screens,various types of graphical user interfaces (GUIs), touch screens,microphones and other types of sensors that may receive some form ofhuman-generated stimulus and generate a signal in response thereto.

It should be appreciated that all combinations of the foregoing conceptsand additional concepts discussed in greater detail below (provided suchconcepts are not mutually inconsistent) are contemplated as being partof the inventive subject matter disclosed herein. In particular, allcombinations of claimed subject matter appearing at the end of thisdisclosure are contemplated as being part of the inventive subjectmatter disclosed herein.

These and other aspects of the invention will be apparent from andelucidated with reference to the embodiment(s) described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention.

FIG. 1 is a schematic representation of an oral care device, inaccordance with an embodiment.

FIG. 2 is a schematic representation of a head of an oral care device,in accordance with an embodiment.

FIG. 3 is a schematic representation of a head of an oral care device,in accordance with an embodiment.

FIG. 4 is a schematic representation of an inflammation localizationsystem, in accordance with an embodiment.

FIG. 5 is a flowchart of a method for localizing gingiva inflammation,in accordance with an embodiment.

FIG. 6 is a schematic representation of a light emitting or samplingscheme, in accordance with an embodiment.

FIG. 7 is a graph of simulated results for data obtained using a priorart method and a centroid sampling method in accordance with anembodiment.

FIG. 8 is a schematic representation of a centroid sampling scheme foran oral care device, in accordance with an embodiment.

DETAILED DESCRIPTION OF EMBODIMENTS

The present disclosure describes various embodiments of a method anddevice for detecting gingival inflammation using an oral care device.More generally, Applicant has recognized and appreciated that it wouldbe beneficial to provide a system to detect localized tissueinflammation. Accordingly, the methods described or otherwise envisionedherein provide a device such as an oral care device configured to obtainmeasurements of gingival tissue. The oral care device comprises one ormore of a variety of sensor arrays having one or more light emitters andat least one light detector to obtain information about gingival tissueone or more sampled locations. The light sources of the one or morelight emitters are configured to emit light such that a plurality ofdifferent wavelengths are sequentially emitted in a first sequentialpattern, and then emitted in a second sequential pattern which is thereverse of the first sequential pattern. One or more light detectors areconfigured to obtain reflectance measurements from a location within theuser's mouth to generate first reflectance data and second reflectancedata for the location in response to light detected in the first andsecond patterns, respectively. A controller of the device averages thefirst reflectance data and second reflectance data to generate averagedreflectance data for the location, which is then used to determinewhether gingiva at the location is inflamed. The oral care device canthen report that information to the user or a third party.

The embodiments and implementations disclosed or otherwise envisionedherein can be utilized with any oral device, including but not limitedto a toothbrush, a flossing device, an oral irrigator, or any other oraldevice. For example, one application of the embodiments andimplementations herein is to assess inflammation of gingival tissuesusing a specialized handheld oral inflammation detection device. Anotherapplication is to assess inflammation of gingival tissues using an oralcare device. However, the disclosure is not limited to a device such asdescribed herein, and thus the disclosure and embodiments disclosedherein can encompass any oral device.

Referring to FIG. 1, in one embodiment, is an oral care device 10 with abody portion 12 and a nozzle member 14 mounted on the body portion.According to an embodiment, nozzle member 14 may beconfigured to allowthe passage of pressurized liquid and/or air from a reservoir in thebody 12 (not shown) to the nozzle head where it is applied to the user'sinterdental regions. Nozzle member 14 can be detachably mounted ontobody portion 12 such that the nozzle can periodically be replaced with anew one when a component of the device is worn out or otherwise requiresreplacement.

Body portion 12 is further provided with a user input 26. The user input26 allows a user to operate the oral care device 10, for example to turnthe oral care device on and off. The user input 26 may, for example, bea button, touch screen, or switch.

Oral care device 10 optionally includes one or more sensors 28. Sensor28 is shown in FIG. 1 within body portion 12, but may be locatedanywhere within the device. Sensor 28 may be used to characterize theorientation and displacement of the device. According to an embodiment,these sensors provide information about the position of the device withrespect to a user's body part, a fixed point, and/or one or more otherpositions. According to an embodiment, sensor 28 is disposed in apredefined position and orientation in the oral cleaning device 10, andthe nozzle is in a fixed spatial relative arrangement to sensor 28.Therefore, the orientation and position of the nozzle can be easilydetermined based on the known orientation and position of the sensor 28.

The information generated by the sensor 28 is provided to a controller30. Controller 30 may be formed of one or multiple modules, and isconfigured to operate the oral cleaning device 10 in response to aninput, such as input obtained via user input 26. According to anembodiment, the sensor 28 is integral to the controller 30. Controller30 can comprise, for example, at least a processor 32, a memory 34, anda connectivity module 38. The processor 32 may take any suitable form,including but not limited to a microcontroller, multiplemicrocontrollers, circuitry, a single processor, or plural processors.The memory 34 can take any suitable form, including a non-volatilememory and/or RAM. The non-volatile memory may include read only memory(ROM), a hard disk drive (HDD), or a solid state drive (SSD). The memorycan store, among other things, an operating system. The RAM is used bythe processor for the temporary storage of data. According to anembodiment, an operating system may contain code which, when executed bycontroller 30, controls operation of the hardware components of oralcleaning device 10. According to an embodiment, connectivity module 38transmits collected sensor data, and can be any module, device, or meanscapable of transmitting a wired or wireless signal, including but notlimited to a Wi-Fi, Bluetooth, near field communication, and/or cellularmodule.

According to an embodiment, oral care device 10 includes a userinterface 46 configured to provide information to a user before, during,and/or after a care session. The user interface 46 can take manydifferent forms, but is configured to provide information to a user. Forexample, the information can be read, viewed, heard, felt, and/orotherwise interpreted concerning inflammation of one or more tissueswithin the mouth. According to an embodiment, the user interface 46provides feedback to the user that includes information about wheretissues are inflamed, and/or how much inflammation is present.Accordingly, the user interface may be a display that providesinformation to the user, a haptic mechanism that provides hapticfeedback to the user, a speaker to provide sounds or words to the user,or any of a variety of other user interface mechanisms. For example, thesystem may provide feedback via a smartphone app, a website, or via anyother interface configured to share information with the user.

Referring to FIG. 2, in one embodiment, is a nozzle 14 of an oral caredevice. The nozzle includes a nozzle head portion, with acentrally-located guidance tip 18. According to one embodiment, thenozzle head comprises at least one light emitter 42 and at least onelight receiver 40. According to the embodiment depicted in FIG. 2, thelight emitter 42 is a ring-shaped bundle of light-emitting fibers or alight-emitting light guide, although it can be many other shapes andsizes. The one or more light emitters can be or comprise any lightsource, such as an LED light source, that emits light capable offacilitating the detection of gingival inflammation. According to anembodiment, the one or more light emitters comprise light from one ormore light sources 48 such as LEDs, and are connected by a light fiberor light guide from the LEDs to the light emitter on the surface of theoral care device. According to an embodiment the light source generateslight in at least two wavelengths, such as 480 nm and 680 nm that allowsfor the characterization of oxygen saturation in human tissue, and hencethe detection of localized inflammation. Generally, tissue exhibitinglow tissue oxygenation indicates gingival inflammation.

Similarly, the one or more light receivers 40 are any light receiverscapable of facilitating the detection of gingival inflammation. Forexample, according to an embodiment the light receivers are aphotodetector or photodiode, or any other sensor capable of detectinglight emitted by the light emitter 42. According to an embodiment, thelight receivers are photodiodes connected to light fibers or lightguides. Each light receiver may be configured to detect two or morewavelengths, or alternatively each light receiver may be configured todetect only a single wavelength. According to another embodiment, lightreceiver 40 is a pixel array configured to obtain one or more images ofthe tissue illuminated by the light emitted from the light emitter 42.The light receiver may comprise a plurality of detection fibers that areused simultaneously or may be time-multiplexed.

One advantage of the design of the oral care device in FIG. 2 is thatthe sensors are able to capture spatial information as well as gingivalinflammation information. Since the information associated with eachemitter-receiver couple comes from a unique tissue location, thelocalization of the inflammation is known.

In this embodiment, the guidance tip 18 provides a tactile feedback tothe user, which facilitates proper interdental positioning near thegums. According to an embodiment, when properly positioned in the mouth,each light receiver 40 measures measures a different part of the tissuesurface, which is approximately the location between the light emitterand the light receiver. For example, when placed on the junction betweentwo teeth and the gingiva the light emitter will illuminate the wholearea, and several light receivers 40 will be on the gingiva to detectinflammation, while others will be simultaneously placed on the teethwhich can be easily distinguished from the measured spectral response.

According to an embodiment, many different configurations of lightemitters 42 and light detectors 40 are possible. Referring to FIG. 3,for example, is an embodiment of an oral care device 10 configuredprimarily to measure gingival inflammation. The oral care devicecomprises a head portion having a single centralized light emitter 42and a plurality of light detectors 40. According to a similarembodiment, the device may comprise a single centralized light detector40 and one or more light emitters 42.

The one or more light emitters 42 and light detectors 40 are positionedon device 10 such that the surfaces of the gingival tissue from whichdata is obtained are not directly illuminated by the light emitter. Forexample, referring to FIG. 2, the light emitter 42 emits light into thetissue in front of it, and light detector 40 obtains reflectance datafrom the tissue located at or very near the “X” shown on the device,although the light detector could also obtain reflectance data from thetissue located in front of it as well. According to an embodiment,therefore, the light emitters and the surfaces from which data isobtained are not overlapping. This is in contrast to a camera system inwhich imaged surfaces are directly illuminated. When a surface isdirectly illuminated, for example, detection or an image is dominated bynear-surface scattering, which prevents the analysis of the gingivaltissue as described herein.

Referring to FIG. 4, in one embodiment, is an inflammation localizationsystem 400. According to an embodiment, inflammation localization system400 includes a controller 30 comprising a processor 32 and a memory 34.The inflammation localization system also comprises a one or more lightemitters 42 each with one or more light sources 48. Inflammationlocalization system 400 includes one or more light detectors 40 whichprovide sensor data to the controller 30. Controller 30 of inflammationlocalization system 400 includes a centroid module 410 which averagesreflectance data received by the light detectors to generate averagedreflectance data for a location, which is used to determine whethergingiva at the location is inflamed.

Controller 30 of inflammation localization system 400 includes aninflammation detection and localization module 420. The inflammationdetection and localization module analyzes averaged reflectance datafrom centroid module 410 to determine whether the analyzed tissue isinflamed and where that tissue is located. The inflammation detectionand localization module may also optionally include device localizationinformation from sensor 28.

According to an embodiment, inflammation localization system 400includes a user interface 46 which provides information to the userabout the status and/or location of the tissue. User interface 46 can beor can comprise a feedback module that provides direct feedback to theuser via a haptic signal, audio signal, visual signal, and/or any othertype of signal.

According to an embodiment, inflammation localization system 400 can beimplemented in any device configured to come into proximity with tissuesthat can be quantified. For example, inflammation localization system400 can be implemented as another oral care device such as a toothbrush,an oral irrigator, a tongue cleaner, or any other oral care device.

Referring to FIG. 5, in one embodiment, is a flowchart of a method 500for localizing inflammation of gingival tissue within a user's mouth. Instep 510, an inflammation localization system 400 is provided. Theinflammation localization system may be any of the devices or systemsdescribed or otherwise envisioned herein. Generally, the inflammationlocalization system will comprise one or more light emitters 42 with oneor more light sources 48, one or more light detectors 40, a centroidmodule 410 configured to average reflectance data received by the lightdetectors to generate averaged reflectance data for a location, and aninflammation detection and localization module 420 configured to analyzethe averaged reflectance data to identify inflamed gingiva. Many othercomponents and configurations are possible. Although method 500 isdescribed within the framework of an oral care device 10, the method canbe implemented using any other inflammation localization analysissystem.

At step 520 of the method, the one or more light emitters 42 emit light,a beam of each of which impacts the gingival tissue. According to anembodiment, the emitted light only indirectly impacts the gingivaltissue that is analyzed by the light detector 40. A light emitter maycomprise one or more light sources 48, and the system may be configuredto activate the one or more light emitters in response to a trigger. Thelight emitters may be spaced apart or co-located, depending on thedesign of the device.

At least some of the one or more light emitters are configured such thatdifferent wavelengths of light are emitted. For example, the device maybe configured such that different wavelengths are emitted by differentlight emitters, and/or the device may be configured such that differentwavelengths are emitted by different light sources 48 of a light emitter42. As a result, the device comprises a plurality of emitted lightwavelengths. According to an embodiment, for effective gingivitisdetection, several wavelengths must be sampled at each location to givea measured spectrum from which tissue oxygenation can be measured andgingival condition can be assessed. For example, high oxygenationindicated gum health while low oxygenation indicated gingivitis. Thenumber of wavelengths can be as low as two, or it can be a detailedspectrum with hundreds of channels, although for most purposes thenumber of wavelengths is between four and eight.

According to an embodiment, the one or more light emitters 42 emit lightsequentially in a first pattern. Referring to FIG. 6, for example, is aschematic representation of a light emitting or sampling scheme 600. Inthis example, the one or more light emitters cycle through eight LEDs,at least some of which are configured to emit light having differentwavelengths than one or more of the other LEDs. The sampling scheme alsocomprises a dark period to detect ambient light, which may be optional.During a first time period 610, light is emitted sequentially by LEDs inthe following first pattern: LED 1, LED 2, LED 3, LED 4, LED 5, LED 6,LED 7, LED 8, and Dark.

At step 530 of the method, the one or more light emitters 42 again emitlight, a beam of each of which impacts the gingival tissue. According toan embodiment, the one or more light emitters 42 of oral care device 10emit light sequentially in a second pattern which is in a reverse ordercompared to the first pattern. Referring to FIG. 6, for example, the oneor more light emitters cycle through the eight LEDs to emit lightsequentially in the second, reverse pattern during time period 620:Dark, LED 8, LED 7, LED 6, LED 5, LED 4, LED 3, LED 2, and LED 1.

The order reverses again, and at time period 630 the one or more lightemitters cycle through the eight LEDs to emit light sequentially in thefirst pattern: LED 1, LED 2, LED 3, LED 4, LED 5, LED 6, LED 7, LED 8,and Dark. As discussed below, averaging can occur between the dataobtained in time periods 610 and 620, and/or between the data obtainedin time periods 620 and 630.

At step 540 of the method, at least one light detector 40 obtainsreflectance data, such as reflectance from the surfaces reflecting lightemitted by the one or more light emitters 42, during the emission oflight at steps 520 and 530. The light detector may obtain datacontinuously or may only obtain data in response to a trigger. Forexample, the light detector may be triggered to obtain sensor data inresponse to activation of a light emitter.

As discussed herein, the light detector 40 may be positioned in anon-overlapping position relative to the light emitter 42 such that thedetected tissue is only indirectly illuminated by the light from thelight emitter. This configuration of the light detector(s) and the lightemitter(s) results in a significant improvement in both the device anddetection of inflammation. For example, the non-overlappingconfiguration described or otherwise envisioned herein maximizes thesignal-to-noise ratio and enhances detection of localized gingivalinflammation, among other benefits, by reducing near-surface scatteringand other inhibitory factors. The one or more light detectors 40 of theoral care device can be positioned in any position in or on the oralcare device, and may be positioned to obtain information about a varietyof locations of the mouth or other surface being analyzed.

According to an embodiment, the one or more light detectors 40 arebroadband detectors configured to obtain broadband spectral data. Thelight detectors will be configured to obtain, at a minimum, data for thewavelengths necessary to evaluate the oxygenation of the gingiva, todistinguish between gingiva and non-gingiva tissue, and/or otherparameters necessary to perform care using the device. According toanother embodiment, the one or more light detectors 40 are narrowbanddetectors configured to obtain narrowband spectral data. Accordingly,the one or more light emitters 42 can be configured to emit coded lightusing a single light source 48 such as a white LED, and the receivinglight detector 40 and/or controller will split the received light intoseveral wavebands for detection.

Once the one or more light detectors 40 obtains reflectance data, thatdata can be communicated continuously or periodically to the controller.Optionally, the obtained reflectance data can be stored in a temporaryor long-term memory for analysis at a later time.

At step 550 of the method, the controller 30 of oral care device 10 hasreceived the first and second reflectance data obtained by the one ormore light detectors 40 and averages the pair of samples for the samewavelength to create averaged reflectance data. That is, centroid module410 of the controller 30 averages, for each wavelength, the reflectancedata obtained at a wavelength while the first pattern was being executedduring time period 610, with the reflectance data obtained at the samewavelength while the second pattern was being executed during timeperiod 620. This results in a common average time point for the reading,which is the same over all color channels, resulting in fewer spectrumsampling errors. According to an embodiment each reading can be usedtwice, averaged with a previous reading and then averaged with asubsequent reading. Accordingly, a higher rate of sampling is notneeded.

If motion experienced by the device is perfectly linear, the averagingscheme eliminates all motion artefacts from the measured spectrum.However, motion is not always linear in practice. Referring to FIG. 7 isa graph of simulated results for data obtained using prior art or“convention” methods and data obtained using the common centroidsampling method described herein, both in the presence of device motionat up to 10 Hz caused by a user's hand. Although both schemes improve assampling rate (Hz) increases, since this reduces the amount of motionbetween samples, the common centroid sampling method decreases at afaster rate, thereby resulting in a significantly lower sampling rateneeded for a given noise level. The advantage increases as the samplingfrequency increases compared to the motion, as the linear approximationbecomes more nearly correct.

According to an embodiment, the device may obtain reflectance data asdescribe herein for multiple locations, thereby requiring multiple lightemitters 42. This may be desirable to deal with the variety of ways thata user can position the device, as well as due to the varying oralgeometry between locations. According to an embodiment it may benecessary to sample the full spectrum, or multiple wavelengths, at eachphysical location in turn, as compared to sampling all physicallocations for a first color channel, then a second color channel, and soon, in order to minimize motion during the reflectance measurement.Motion between each physical site measurement does not lead to errors inmeasuring tissue apparent oxygenation.

According to an embodiment, therefore, it may be advantageous to measureboth the first emission pattern and the second, reverse emission patternfor each location individually. The device will measure reflectance at afirst location before moving to sampling at a second location, and soon. This allows for the centroid method to be utilized at each locationat a high effective sampling rate, which provides improved effectivenoise compared to only one direction of sampling for each physical site.Provided there are more than two physical sites to measure, the overallsampling rate required for a given noise level is lower when using thisscheme. A lower overall sampling rate is not only advantageous due tolower loading on the microcontroller, but it also improvessignal-to-noise rations throughout the system. Indeed, at highersampling rates, the overall number of photons detected per sample dropslinearly, and the overall noise increases as the square root of samplingspeed, due to the higher bandwidth needed for the photodiode amplifiercircuits.

Referring to FIG. 8, in one embodiment, is a schematic representation ofa centroid sampling scheme 800 for a device with a single white LEDlight emitter, where one and a receiving light detector defines thewavelength. For example, each light detector can be connected to acommon light guide and can comprise a band pass filter to select thewavelength. In this example, wavelength separation occurs at the levelof the light detectors 40, and the one or more light emitters 42 eachilluminate a different physical location of the gingiva, detected by acommon detection spot coupled to the photodetectors. By scanning eachlight detector in both directions in each illumination time slot, themotion cancelation effective frequency remains high, even though thereare long gaps in time between each LED being scanned.

At optional step 560 of the method, controller 30 of oral care device 10analyzes the averaged reflectance data to determine which of theplurality of analyzed locations are and/or are not gingiva. According toone embodiment, the inflammation detection and localization module 420,which can be implemented as an algorithm, analyzes the averagedreflectance data in one or more steps. For example, as an initial step,the module rejects potential outliers in the data. Outliers may includespurious measurements, as well as reflectance data from objects that arelikely not gingival tissues, such as food debris, teeth, and otherobjects. Since the absorption spectra of objects such as teeth and fooddebris vary considerably from the absorption spectra of gingival tissue,the two can be distinguished. According to an embodiment, outliers aredetected at points with absorption spectra that do not correspond togingival tissue, essentially not showing the sharp spectralcharacteristics of hemoglobin absorption.

According to an embodiment, inflammation detection and localizationmodule 420 determines a reflectance ratio of two or more differentwavelengths. Using sample data of spectra obtained at 550 nm and 660 nm,for example, a ratio of reflectance would provide values of 2.38 forgingival tissue and 1.21 for teeth. Similarly, a ratio of reflectancebetween a blue wavelength (400 nm to 480 nm) and a green wavelength (480nm to 550 nm) would provide values of 5.96 for gingival tissue and 1.44for teeth. Therefore, the inflammation detection and localization module420 could be configured or programmed with predetermined thresholds toidentify gingival tissue. According to an embodiment, the systemcompares the reflectance ratio to the predetermined threshold andcharacterizes the location as being gingiva or non-gingiva based onwhether the determined reflectance ratio exceeds or does not exceed thepredetermined threshold. As just one example, a threshold of 2 in bothof the above examples would decipher between gingiva and non-gingiva;reflectance ratios above 2 are characterized as gingiva, and reflectanceratios below 2 are characterized as non-gingiva. The system would thendiscard data from non-gingiva and would only continue to analyze dataobtained from gingiva.

According to another embodiment, at step 550 of the method the systemanalyzes the obtained reflectance data to determine which of theplurality of analyzed locations are and/or are not gingiva by weightingthe reflectance data. For example, the system may apply a high weight toreflectance data indicative of gingiva, and/or may apply a low weight toreflectance data indicative of anything other than gingiva. A systemconfigured to weight reflectance data may only apply a weight toreflectance data indicative of gingiva, may only apply a weight toreflectance data indicative of non-gingiva, or may apply weights to bothconditions during an analysis. The weighting process may be a programmedor predetermined weighting process, or may be a machine-learnedweighting process. Using a weighting process, the system may utilize theone or more weighting factors to focus on reflectance data indicative ofgingiva for further analysis, including an analysis of possibleinflammation. In addition to removing non-gingiva reflectance data, andweighting gingiva and/or non-gingiva reflectance data, other methods ofdetermining which of the plurality of analyzed locations are gingiva arepossible.

At step 570 of the method, the controller 30 of oral care device 10analyzes the averaged reflectance data to determine which of theplurality of analyzed locations comprise inflamed gingiva. For example,the inflammation detection and localization module 420 analyzes theaveraged reflectance data for all locations or only at locationsdetermined to comprise gingiva. This analysis can be done while thedevice is obtaining data, or may be completed after the oral care devicehas finished with a session, or it may be performed on demand from theuser.

According to an embodiment, the inflammation detection and localizationmodule 420 determines or characterizes an approximate tissue oxygenationlevel of the gingival tissue using the averaged reflectance data. Sincetissue oxygen saturation is significantly decreased in gingivitis andperiodontitis locations compared to healthy locations, the module mayselect a signal exhibiting the lowest tissue oxygenation, whichidentifies the highest level of gingival inflammation. This may beperformed, for example, by selecting the maximum value from a given setof data, or by taking the average of the X-top percentile from a givenset of data, among other methods. The module may obtain thisinformation, for example, at each locale for which data was obtained.The inflammation detection and localization module 420 will thusgenerate information about locations within the mouth where there islikely to be gingival inflammation.

At step 580 of the method, the system or device optionally providesfeedback to the user and/or a third-party regarding the inflammationlocalization information. The user interface 46 of the oral care device10, for example, can provide direct and/or indirect feedback to the userwhile the oral care device is being used, or after a cleaning orscanning session. As an example, the device can provide direct feedbackto the user after each measurement using audio, visual, haptic, and/ordigital feedback whenever inflammation is detected.

According to another embodiment, the system or device may providefeedback to the user after a scanning session is complete. As anexample, the system or device may provide feedback once a scanningsession is complete by means of visual representation where theinflammation levels are displayed. The feedback may include, forexample, a mouth map—using location sensing technology duringmeasurement—either in their absolute form to show the inflammationlevels or in relative forms to highlight one or more specific sites.According to an embodiment, the device can scale or otherwise rankinflammation levels using a variety of colors or other physicalrepresentations. For example, the user may only focus on areas ofsignificant inflammation, or inflammation above a certain level.

According to an embodiment, the inflammation data is stored and/orcommunicated with a third party, either locally or remotely. Forexample, according to an embodiment, a patient may be instructed to usethe oral care device during an appointment with a dental careprofessional, to assess inflammation. The inflammation information willthen be communicated to the dental care professional, using a report orother mechanism. As another example, a user may collect inflammationdata that is automatically or periodically transmitted to a remotehealthcare professional or other intended or authorized entity where itcan be analyzed continuously or during an appointment with the user.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Multiple elements listed with“and/or” should be construed in the same fashion, i.e., “one or more” ofthe elements so conjoined. Other elements may optionally be presentother than the elements specifically identified by the “and/or” clause,whether related or unrelated to those elements specifically identified.

As used herein in the specification and in the claims, “or” should beunderstood to have the same meaning as “and/or” as defined above. Forexample, when separating items in a list, “or” or “and/or” shall beinterpreted as being inclusive, i.e., the inclusion of at least one, butalso including more than one, of a number or list of elements, and,optionally, additional unlisted items. Only terms clearly indicated tothe contrary, such as “only one of” or “exactly one of,” or, when usedin the claims, “consisting of,” will refer to the inclusion of exactlyone element of a number or list of elements. In general, the term “or”as used herein shall only be interpreted as indicating exclusivealternatives (i.e. “one or the other but not both”) when preceded byterms of exclusivity, such as “either,” “one of,” “only one of,” or“exactly one of.”

As used herein in the specification and in the claims, the phrase “atleast one,” in reference to a list of one or more elements, should beunderstood to mean at least one element selected from any one or more ofthe elements in the list of elements, but not necessarily including atleast one of each and every element specifically listed within the listof elements and not excluding any combinations of elements in the listof elements. This definition also allows that elements may optionally bepresent other than the elements specifically identified within the listof elements to which the phrase “at least one” refers, whether relatedor unrelated to those elements specifically identified.

It should also be understood that, unless clearly indicated to thecontrary, in any methods claimed herein that include more than one stepor act, the order of the steps or acts of the method is not necessarilylimited to the order in which the steps or acts of the method arerecited.

In the claims, as well as in the specification above, all transitionalphrases such as “comprising,” “including,” “carrying,” “having,”“containing,” “involving,” “holding,” “composed of,” and the like are tobe understood to be open-ended, i.e., to mean including but not limitedto. Only the transitional phrases “consisting of” and “consistingessentially of” shall be closed or semi-closed transitional phrases,respectively.

While several inventive embodiments have been described and illustratedherein, those of ordinary skill in the art will readily envision avariety of other means and/or structures for performing the functionand/or obtaining the results and/or one or more of the advantagesdescribed herein, and each of such variations and/or modifications isdeemed to be within the scope of the inventive embodiments describedherein. More generally, those skilled in the art will readily appreciatethat all parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the inventive teachingsis/are used. Those skilled in the art will recognize, or be able toascertain using no more than routine experimentation, many equivalentsto the specific inventive embodiments described herein. It is,therefore, to be understood that the foregoing embodiments are presentedby way of example only and that, within the scope of the appended claimsand equivalents thereto, inventive embodiments may be practicedotherwise than as specifically described and claimed. Inventiveembodiments of the present disclosure are directed to each individualfeature, system, article, material, kit, and/or method described herein.In addition, any combination of two or more such features, systems,articles, materials, kits, and/or methods, if such features, systems,articles, materials, kits, and/or methods are not mutually inconsistent,is included within the inventive scope of the present disclosure.

1. A method for localizing gingival inflammation within a user's mouthusing an oral care device, the method comprising: sequentially emittinglight by a plurality of light sources of the oral care device in a firstsequential pattern, wherein at least some of the plurality of lightsources are configured to emit light of different wavelengths to resultin a plurality of emitted light wavelengths; sequentially emitting lightby the plurality of light sources of the oral care device in a secondsequential pattern, wherein the second sequential pattern is the reverseof the first sequential pattern; obtaining, by a light detector of theoral care device, reflectance measurements from a location within theuser's mouth to generate first reflectance data for the location inresponse to the light emitted in the first sequential pattern, and togenerate second reflectance data for the location in response to thelight emitted in the second sequential pattern; averaging, by acontroller of the oral care device, first reflectance data and secondreflectance data for each of the plurality of emitted light wavelengthsto generate averaged reflectance data; and determining, by thecontroller using the averaged reflectance data, whether gingiva at thelocation is inflamed.
 2. The method of claim 1, further comprising thestep of determining, by the controller using averaged reflectance data,whether the location comprises gingiva.
 3. The method of claim 1,further comprising the step of providing information regarding whethergingiva at a location comprises inflammation.
 4. The method of claim 1,wherein the oral care device comprises a plurality of light detectors,each configured to obtain reflectance measurements from a differentlocation within the user's mouth to generate reflectance data for thatrespective location.
 5. The method of claim 1, wherein the step ofdetermining whether gingiva at a location is inflamed comprisesdetermining an approximate tissue oxygenation level of the gingiva,wherein a low tissue oxygenation level indicates gingiva inflammation.6. The method of claim 1, wherein the plurality of light sources and thelight detector are positioned such that a surface at the location is notdirectly illuminated by the plurality of light sources.
 7. The method ofclaim 1, wherein the first and/or second sequential pattern furthercomprises a time point in which no light is emitted by the plurality oflight sources.
 8. A method for localizing gingival inflammation within auser's mouth using an oral care device, the method comprising:sequentially detecting, by one or more light detectors of the oral caredevice, light emitted by one or more light sources of the oral caredevice, wherein the one or more light detectors are configured tomeasure a plurality of wavelengths in a first sequential pattern, andgenerating first reflectance data from the detected light; sequentiallydetecting light by the one or more light detectors of the oral caredevice in a second sequential pattern, wherein the second sequentialpattern is the reverse of the first sequential pattern, and generatingsecond reflectance data from the detected light; averaging, by acontroller of the oral care device, first reflectance data and secondreflectance data for each of the plurality of detected wavelengths togenerate averaged reflectance data; and determining, by the controllerusing the averaged reflectance data, whether gingiva at the location isinflamed.
 9. The method of claim 8, further comprising the step ofdetermining, by the controller using averaged reflectance data, whetherthe location comprises gingiva.
 10. (canceled)
 11. (canceled) 12.(canceled)
 13. (canceled)
 14. (canceled)
 15. (canceled)
 16. (canceled)17. A controller to localize gingival inflammation within a user'smouth, the controller configured to: (i) average first reflectance dataand second reflectance data to generate averaged reflectance data,wherein said first reflectance data is obtained for a location withinthe user's mouth using a light detector to obtain reflectancemeasurements of light emitted from a plurality of light sources in afirst sequential pattern and reflected from the location within theuser's mouth, and wherein second reflectance data is obtained for thelocation within the user's mouth using the light detector to obtainreflectance measurements of light emitted from the plurality of lightsources in a second sequential pattern and reflected from the locationwithin the user's mouth, wherein the second sequential pattern is thereverse of the first sequential pattern, wherein the emitted lightincludes a plurality of emitted light wavelengths, and wherein the firstreflectance data and the second reflectance data is averaged for each ofthe plurality of emitted light wavelengths; and (ii) determine, usingthe averaged reflectance data, whether gingiva at the location isinflamed.
 18. The controller of claim 17, wherein the first sequentialpattern and/or the second sequential pattern comprises a time point inwhich no light is emitted by the plurality of light sources.
 19. Adevice to localize gingival inflammation within a user's mouth, thedevice comprising: a controller according to claim
 17. 20. The device ofclaim 19, wherein the device comprises an oral care device.
 21. A systemto localize gingival inflammation within a user's mouth, the systemcomprising: a controller according to claim 17; the plurality of lightsources; and the light detector.
 22. A system to localize gingivalinflammation within a user's mouth, the system comprising: a controlleraccording to claim 17; and an oral care device wherein the oral caredevice comprises the plurality of light sources and the light detector.